Boehringer Ingelheim’s new autoinjector pen administering Cyltezo (adalimumab-adbm) is now available to patients living with chronic inflammatory diseases in the US.

The Cyltezo pen autoinjector, which is a biosimilar to AbbVie’s blockbuster Humira (adalimumab), received approval from the US Food and Drug Administration (FDA) in May 2023. Boehringer Ingelheim originally received FDA approval for the drug in 2017, and then further approval as an interchangeable biosimilar in 2021.

The 40mg/0.8ml pre-filled Cyltezo Pen will be offered in two, four and six-pack options.

AbbVie has enjoyed a prosperous monopoly of the adalimumab market with Humira generating $21.2bn in global sales in 2022. With several biosimilars likely to flood the market in 2023 and the company losing exclusivity, AbbVie said it expects its sales of the drug to decline 37% in 2023.

Challengers to Humira are now vying for market share. Organon and Samsung Bioepsis launched an autoinjector pen on 1 July, following FDA approval. The product, marketed as Hadlima, will be listed at 85% cheaper than the price of Humira.

Last week, the FDA rejected Alvotech’s Humira biosimilar for the third time over deficiencies in the company’s manufacturing facilities.

In a statement announcing the launch, Boehringer Ingelheim said Cyltezo’s competitive advantage is that it is currently the only approved interchangeable biosimilar to Humira. The company also added that another unique feature of the drug is its Phase III comparative clinical trials in rheumatoid arthritis, plaque psoriasis and Crohn’s disease.

“Biosimilars such as Cyltezo have the potential to increase patient access to critical biologic medicines, which may benefit people living with chronic and often debilitating diseases such as rheumatoid and psoriatic arthritis,” said Steven Taylor, Arthritis Foundation’s president.

“The Crohn’s and colitis patient community welcomes adalimumab biosimilars, including Cyltezo, as new options to treat these inflammatory conditions,” said Michael Osso, president, and CEO of the Crohn’s & Colitis Foundation.

Reference: https://www.pharmaceutical-technology.com/news/cyltezo-pen-first-interchangeable-biosimilar-to-humira-rolls-out-across-us/